MEDTECH NEWS
China's NMPA Issues New Regulations on Medical Device Export Sales Certificates
05 01 2026China's National Medical Products Administration (NMPA) has released updated regulations for medical device export sales certificates, effective May 1, 2026, replacing the 2015 version. The new rules establish two certificate types: Type I for devices already registered in China and Type II for unregistered devices whose manufacturers meet GMP standards. Applications will be processed within 20 working days through provincial authorities, with certificate validity capped at three years for Class I devices. The regulations introduce stricter accountability measures, including a five-year ban for fraudulent applications, while emphasizing that companies remain responsible for ensuring compliance with importing countries' requirements. The NMPA characterized the update as a service measure to facilitate medical device exports while maintaining quality and regulatory standards.